The Trump administration’s rollout of a federal mandate that millions of Americans on Medicaid must work or risk losing health benefits will force states to scrap months of preparation, according to advocates for Medicaid enrollees and consultants advising states. And they say an overhaul — less than seven months before states must start enforcing the requirement — will be costly. Regulations...
Compliance Update
Why FDA’s new Adverse Event Monitoring System matters
FDA’s announcement regarding the launch of AEMS is worth watching. The Adverse Event Monitoring System is intended to consolidate multiple reporting systems across FDA-regulated product categories into a single platform, including medical products, vaccines, devices, tobacco, food, cosmetics, and veterinary products. Legacy systems to be replaced by AEMS now include: FAERS (FDA Adverse Event...
Senate leaders warn Defense Department about procuring generic drugs overseas
Senate leaders are urging the Department of Defense to prioritize the purchase of generic drugs manufactured in the United States, warning that the country’s overreliance on foreign factories poses an “existential risk” to the military. In a letter last week, Sens. Rick Scott, R-Fla., and Kirsten Gillibrand, D-N.Y., asked Defense Department Secretary Pete Hegseth to provide information about...
These 3 policy moves are likely to change healthcare for older people
Month after month, Patricia Hunter and other members of the Nursing Home Reform Coalition logged onto video calls with congressional representatives, seeking support for a proposed federal rule setting minimum staff levels for nursing homes. Finally, after decades of advocacy, the Biden administration in 2023 tackled the problem of perennial understaffing of long-term care facilities. Officials...
Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescribing Controlled Substances
On December 31, 2025, the Drug Enforcement Administration (DEA), jointly with the U.S. Department of Health and Human Services (HHS), published a temporary rule that extends the COVID-era “telemedicine flexibilities” for prescribing Schedule II–V controlled substances through December 31, 2026 (the fourth temporary extension). The rule is effective January 1, 2026 through December 31, 2026, and...
How delays and bankruptcy let a nursing home chain avoid paying settlements for injuries and deaths
Nancy Hunt arrived at an emergency room from a Genesis HealthCare nursing home in Pennsylvania in such dreadful shape, including maggots infesting her gangrened foot, that the hospital called an elder abuse hotline and then the police, her son alleged in a lawsuit. Hunt died five days later. Her death certificate said the foot injury was a “significant” factor. Genesis denied wrongdoing but...